Sirolimus is named as an intervention in 20 current clinical trials in our China, USA and UK registers. 12 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is CSPC ZhongQi Pharmaceutical Technology Co., Ltd (5). The most-studied condition is HR+/HER2- Advanced/Metastatic Breast Cancer. The EU clinical trials register (CTIS) separately lists 6 authorised or ongoing trials.
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Sirolimus. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
7 single-substance products containing Sirolimus on the HPRA medicines list.
No entry for Sirolimus in the EMA, FDA or German BfArM shortage lists we track.
| Condition (as registered) | Trials |
|---|---|
| HR+/HER2- Advanced/Metastatic Breast Cancer | 2 |
| Systemic Lupus Erythematosus | 2 |
| Gaucher Disease, Type 2 | 1 |
| X-Linked Myotubular Myopathy | 1 |
| Duchenne Muscular Dystrophy | 1 |
| Parkinson Disease | 1 |
| Cavernous Malformations | 1 |
| Intracerebral Hemorrhage | 1 |
| Brainstem Stroke | 1 |
| Kaposiform Hemangioendothelioma | 1 |
| Advanced HR - Positive, HER2 - Negative Breast Cancer | 1 |
| Resistant to (Neo)Adjuvant Endocrine Therapy | 1 |
| Epithelioid Hemangioendothelioma | 1 |
| Advanced Solid Tumors | 1 |
| Retroperitoneal Fibrosis | 1 |
| Warm Autoimmune Hemolytic Anemia | 1 |
| Aplastic Anaemia | 1 |
| Gastroenteropancreatic Neuroendocrine Tumors | 1 |
| Immune Thrombocytopenia | 1 |
| Antiphospholipid (aPL)-Positive | 1 |
| Thrombocytopaenia | 1 |
| Kaposiform Hemangioendothelioma (KHE) | 1 |
| Kasabach Merritt Phenomenon | 1 |
| Lymphatic Malformation | 1 |
| Lead sponsor | Trials |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | 5 |
| Prevail Therapeutics | 2 |
| Chinese SLE Treatment And Research Group | 2 |
| West China Hospital | 2 |
| Peking Union Medical College Hospital | 2 |
| Astellas Gene Therapies | 1 |
| Sarepta Therapeutics, Inc. | 1 |
| Huashan Hospital | 1 |
| Fudan University | 1 |
| Peking University International Hospital | 1 |
| Peking University First Hospital | 1 |
| Yi Ji | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 16 | 11 |
| Clinical trials in USA | 4 | 1 |
| Clinical trials in UK | 1 | 0 |
| EU register (CTIS) | 6 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
20 current trials in our China, USA and UK registers name Sirolimus as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.
Yes. 12 of the 20 trials are recruiting: 11 with sites in China and 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd (5), Prevail Therapeutics (2), Chinese SLE Treatment And Research Group (2) and West China Hospital (2), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 7 single-substance products containing Sirolimus, for example HYFTOR 2 mg/g Gel (Plusultra Pharma GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Sirolimus has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Sirolimus works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Sirolimus works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Sirolimus (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.